Risks and benefits of research on children: developing an ethical framework to meet children's needs

This is the authors' abstract. We don't add key points for this paper.

Children are put at unnecessary risk in everyday clinical practice by being given medicines whose safety and efficacy have not been adequately researched. The lack of appropriate dosage forms for many ‘essential medicines’ for the main five treatable conditions causing the deaths of 10 million children worldwide under the age of 5 years are a major reason why countries are not achieving their millennium developmental goals. There has been understandable reluctance to undertake the necessary research on children. The reasons for this are reviewed. The existing levels of protection for child subjects worldwide are insufficient. Key principles are suggested both to encourage clinical research and to ensure adequate protection for children around the world.